notify the Secretary of the identity and location of 
a drug, if such person has reason to believe— 
‘‘(A) that such drug, when introduced into 
or while in interstate commerce, or while held 
for sale (regardless of whether the first sale) 
after shipment in interstate commerce, is adul-
terated or misbranded; and 
‘‘(B) there is a reasonable probability that 
the use or consumption of, or exposure to, the 
drug (or an ingredient or component used in 
any such drug) will cause a threat of serious 
adverse health consequences or death to hu-
mans or animals. 
‘‘(2) MANNER OF NOTIFICATION.—Notification 
under paragraph (1) shall be made in such manner 
and by such means as the Secretary may require by 
regulation or guidance. 
‘‘(b) VOLUNTARY RECALL.—The Secretary may re-
quest that any person who distributes a drug that the Sec-
retary has reason to believe is adulterated, misbranded, 
or otherwise in violation of this Act voluntarily— 
‘‘(1) recall such drug; and 
‘‘(2) provide for notice, including to individuals 
as appropriate, to persons who may be affected by 
the recall. 
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‘‘(c) ORDER TO CEASE DISTRIBUTION AND RECALL 
DRUG AND RELATED PROCEDURES.— 
‘‘(1) ISSUANCE OF ORDER.—If the Secretary 
has reason to believe that the use or consumption of, 
or exposure to, a drug (or an ingredient or compo-
nent used in any such drug) may cause serious ad-
verse health consequences or death to humans or 
animals, the Secretary shall have the authority to 
issue an order requiring any person who distributes 
such drug— 
‘‘(A) to immediately cease distribution of 
such drug; and 
‘‘(B) to provide for notice, including to in-
dividuals as appropriate, to persons who may be 
affected by such cessation of distribution. 
‘‘(2) ACTION FOLLOWING ORDER.— 
‘‘(A) CEASE DISTRIBUTION AND NOTIFICA-
TION.—Any person who is subject to an order 
under paragraph (1) shall immediately cease 
distribution of such drug and provide notifica-
tion as required by such order. 
‘‘(B) APPEAL.—Any person who is subject 
to an order under paragraph (1) may appeal 
within 24 hours of issuance such order to the 
Secretary. Such appeal may include a request 
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for an informal hearing and a description of 
any efforts to recall such drug undertaken vol-
untarily by the person, including after a request 
under subsection (b). 
‘‘(C) INFORMAL HEARING.—Except as pro-
vided in subsection (d), if an appeal made 
under subparagraph (B) contains a request for 
an informal hearing, such hearing shall be held 
as soon as practicable, but not later than 5 cal-
endar days, or less as determined by the Sec-
retary, after such an appeal is filed, unless the 
parties jointly agree to an extension. 
‘‘(D) DETERMINATION.—After affording 
an opportunity for an informal hearing, the 
Secretary shall determine— 
‘‘(i) whether— 
‘‘(I) the order under paragraph 
(1) should be amended to require a 
recall of such drug; or 
‘‘(II) inadequate grounds exist to 
support the actions required by the 
order; or 
‘‘(ii) that the order under paragraph 
(1) was appropriate as issued. 
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‘‘(E) 
AMENDMENT
OR
VACATION
OF 
ORDER.— 
‘‘(i) AMENDMENT.—In the case of a 
determination made under subparagraph 
(D)(i)(I), the Secretary shall amend the 
order made under paragraph (1) accord-
ingly. 
‘‘(ii) VACATION.—In the case of a de-
termination made under subparagraph 
(D)(i)(II), the Secretary shall vacate the 
order made under paragraph (1). 
‘‘(3) ORDER TO RECALL.— 
‘‘(A) AMENDMENT.—Except as provided 
under subsection (d), if after providing an op-
portunity for an informal hearing under para-
graph (2)(C), the Secretary determines that the 
order should be amended to include a recall of 
the drug with respect to which the order was 
issued, the Secretary shall amend the order to 
require a recall. 
‘‘(B) 
CONTENTS.—An 
amended 
order 
under subparagraph (A) shall— 
‘‘(i) specify a timetable in which the 
recall will occur; 
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